Moving home: Community transition supports for people with intellectual and developmental disabilities

BackgroundIn recognition of the important role housing plays in people's health and quality of life, Medicaid Home- and Community-Based Services (HCBS) programs are more frequently working to promote the housing security of Medicaid beneficiaries. One mechanism states use to promote housing security of people with intellectual and developmental disabilities (IDD) is to offer community transition services in their HCBS programs. Community transition services help with transition by assisting with securing housing and leases, obtaining basic furnishings, paying for utility setup, funding moving expenses, and making accessibility adaptations.ObjectiveThe aim of this study was to examine if and how states provided community transition services in their HCBS waiver programs for people with IDD.MethodsWe analyzed 107 fiscal year (FY) 2021 HCBS 1915(c) waivers for people with IDD from across the United States. We analyzed the service expenditures and utilization data for community transition services, including projected spending, projected number of users served, reimbursement rates, projected spending per participant, and annual service provision per participant.ResultsIn FY2021, 49 waivers (45.8%) from 28 states provided community transition services to people with IDD. A total of $7.21 million of spending was projected for community transition services for 2405 people with IDD, with an average spending per person of $2303.ConclusionsWhile community transition services can help promote the housing insecurity of people with IDD, there was wide variance in how these services were allocated to people with IDD in FY2021.     

Perceived impacts of COVID-19 on wellbeing among US working-age adults with ADL difficulty

BackgroundThe COVID-19 pandemic has disproportionately impacted people with disabilities. Working-age adults with ADL difficulty may face unique challenges and heightened health risks because of the pandemic. It is critical to better understand the impacts of COVID-19 on social, financial, physical, and mental wellbeing among people with disabilities to inform more inclusive pandemic response policies.ObjectiveThis study compares perceived COVID-19 physical and mental health, social, and financial impacts for US working-age adults with and without ADL difficulty.MethodsWe analyzed data from a national survey of US working-age adults (aged 18–64) conducted in February and March 2021 (N = 3697). We used logistic regression to compare perceived COVID-19-related impacts on physical and mental health, healthcare access, social relationships, and financial wellbeing among those with and without ADL difficulty.ResultsAdults with ADL difficulty were more likely to report negative COVID-19 impacts for many but not all outcomes. Net of covariates, adults with ADL difficulty had significantly greater odds of reporting COVID-19 infection (OR = 2.1) and hospitalization (OR = 6.7), negative physical health impacts (OR = 2.0), and negative impacts on family relationships (OR = 1.6). However, they had significantly lower odds of losing a friend or family member to COVID-19 (OR = 0.7). There were no significant differences in perceived impacts on mental health, ability to see a doctor, relationships with friends, or financial wellbeing.ConclusionsWorking-age adults with ADL difficulty experienced disproportionate health and social harm due to the COVID-19 pandemic. To address these disparities, public health response efforts and social policies supporting pandemic recovery must include disability perspectives.     

Receipt of COVID-19 and seasonal influenza vaccines in California (USA) during the 2021–2022 influenza season

BackgroundDespite lower circulation of influenza virus throughout 2020–2022 during the COVID-19 pandemic, seasonal influenza vaccination has remained a primary tool to reduce influenza-associated illness and death. The relationship between the decision to receive a COVID-19 vaccine and/or an influenza vaccine is not well understood.MethodsWe assessed predictors of receipt of 2021–2022 influenza vaccine in a secondary analysis of data from a case-control study enrolling individuals who received SARS-CoV-2 testing. We used mixed effects logistic regression to estimate factors associated with receipt of seasonal influenza vaccine. We also constructed multinomial adjusted marginal probability models of being vaccinated for COVID-19 only, seasonal influenza only, or both as compared with receipt of neither vaccination.ResultsAmong 1261 eligible participants recruited between 22 October 2021–22 June 2022, 43% (545) were vaccinated with both seasonal influenza vaccine and >1 dose of a COVID-19 vaccine, 34% (426) received >1 dose of a COVID-19 vaccine only, 4% (49) received seasonal influenza vaccine only, and 19% (241) received neither vaccine. Receipt of >1 COVID-19 vaccine dose was associated with seasonal influenza vaccination (adjusted odds ratio [aOR]: 3.72; 95% confidence interval [CI]: 2.15–6.43); this association was stronger among participants receiving >1 COVID-19 booster dose (aOR = 16.50 [10.10–26.97]). Compared with participants testing negative for SARS- CoV-2 infection, participants testing positive had lower odds of receipt of 2021-2022 seasonal influenza vaccine (aOR = 0.64 [0.50–0.82]).ConclusionsRecipients of a COVID-19 vaccine were more likely to receive seasonal influenza vaccine during the 2021–2022 season. Factors associated with individuals’ likelihood of receiving COVID-19 and seasonal influenza vaccines will be important to account for in future studies of vaccine effectiveness against both conditions. Participants who tested positive for SARS-CoV-2 in our sample were less likely to have received seasonal influenza vaccine, suggesting an opportunity to offer influenza vaccination before or after a COVID-19 diagnosis.     

Unmet need for COVID-19 vaccination coverage in Kenya

COVID-19 has impacted the health and livelihoods of billions of people since it emerged in 2019. Vaccination for COVID-19 is a critical intervention that is being rolled out globally to end the pandemic. Understanding the spatial inequalities in vaccination coverage and access to vaccination centres is important for planning this intervention nationally. Here, COVID-19 vaccination data, representing the number of people given at least one dose of vaccine, a list of the approved vaccination sites, population data and ancillary GIS data were used to assess vaccination coverage, using Kenya as an example. Firstly, physical access was modelled using travel time to estimate the proportion of population within 1 hour of a vaccination site. Secondly, a Bayesian conditional autoregressive (CAR) model was used to estimate the COVID-19 vaccination coverage and the same framework used to forecast coverage rates for the first quarter of 2022. Nationally, the average travel time to a designated COVID-19 vaccination site (n = 622) was 75.5 min (Range: 62.9 – 94.5 min) and over 87% of the population >18 years reside within 1 hour to a vaccination site. The COVID-19 vaccination coverage in December 2021 was 16.70% (95% CI: 16.66 – 16.74) – 4.4 million people and was forecasted to be 30.75% (95% CI: 25.04 – 36.96) – 8.1 million people by the end of March 2022. Approximately 21 million adults were still unvaccinated in December 2021 and, in the absence of accelerated vaccine uptake, over 17.2 million adults may not be vaccinated by end March 2022 nationally. Our results highlight geographic inequalities at sub-national level and are important in targeting and improving vaccination coverage in hard-to-reach populations. Similar mapping efforts could help other countries identify and increase vaccination coverage for such populations.     

The impact of the COVID-19 pandemic on hepatitis B virus vaccination and transmission among men who have sex with men: A mathematical modelling study

BackgroundDuring the COVID-19 pandemic, the number of hepatitis B virus (HBV) vaccinations among men who have sex with men (MSM) has been considerably lower than before the pandemic. Moreover, less frequent HBV testing and a reduction in numbers of sex partners have been reported. We assessed the impact of these COVID-19-related changes on HBV transmission among MSM in the Netherlands.MethodsWe estimated the changes in sexual activity, HBV testing, and HBV vaccination among MSM during the pandemic from Dutch data. We used a deterministic compartmental model and investigated scenarios with small or large declines in sexual activity, testing, and vaccination for the current phase of the pandemic (without available data). We examined the increase in HBV vaccinations needed to prevent further increase in HBV incidence.ResultsWith a decrease in numbers of sex partners of 15–25% during the first lockdown and 5% during the second lockdown, we found a decline of 6.6% in HBV incidence in 2020, despite a >70% reduction in HBV testing and vaccination during the first lockdown. With numbers of sex partners rebounding close to pre-pandemic level in 2021, and a reduction of 15% in testing and 30% in vaccination in 2021, we found an increase of 1.4% in incidence in 2021 and 3.1% in 2026. With these changes, an increase of ≥60% in HBV vaccinations in 2022 would be needed to bring the HBV incidence in 2023 back to the level that it would have had if the COVID-19-related changes had not occurred.ConclusionsDespite reductions in sexual activity during the COVID-19 pandemic, the decrease in HBV vaccinations may result in a small increase in HBV incidence after 2021, which may persist for years. It is important to restore the vaccination level and limit further increase in HBV transmission among MSM.     

Influenza vaccination uptake among Canadian adults before and during the COVID-19 pandemic: An analysis of the Canadian Longitudinal study on Aging (CLSA)

IntroductionUnderstanding how influenza vaccine uptake changed during the 2020/2021 influenza season compared to previous pre-pandemic seasons is a key priority, as is identifying the relationship between prior influenza vaccination and COVID-19 vaccine willingness.MethodsWe analyzed data from a large, nationally representative cohort of Canadian residents aged 50 and older to assess influenza vaccination status three times between 2015 and 2020. We investigated: 1) changes in self-reported influenza vaccine uptake, 2) predictors of influenza vaccine uptake in 2020/2021, and 3) the association between influenza vaccination history and self-reported COVID-19 vaccine willingness using logistic regression models.ResultsAmong 23,385 participants analyzed for aims 1–2, influenza vaccination increased over time: 14,114 (60.4%) in 2015–2018, 15,692 (67.1%) in 2019/2020, and 19,186 (82.0%; combining those already vaccinated and those planning to get a vaccine) in 2020/2021. After controlling for socio-demographics, history of influenza vaccination was most strongly associated with influenza vaccination in 2020/2021 (adjusted odds ratio [aOR] 147.9 [95% CI: 120.9–180.9]); this association remained after accounting for multiple health and pandemic-related factors (aOR 140.3 [95% CI: 114.5–171.8]). To a lesser degree, those more concerned about COVID-19 were also more likely to report influenza vaccination in fall 2020, whereas those reporting a very negative impact of the pandemic were less likely to get vaccinated. Among 23,819 participants with information on COVID-19 vaccine willingness during the last quarter of 2020 (aim 3), prior influenza vaccination was most strongly associated with willingness to get a COVID-19 vaccine (aOR 15.1 [95% CI: 13.5–16.8] for those who had received influenza vaccine at all previous timepoints versus none).ConclusionsOur analysis highlights the importance of previous vaccination in driving vaccination uptake and willingness. Efforts to increase vaccination coverage for influenza and COVID-19 should target individuals who do not routinely engage with immunization services regardless of demographic factors.     

Changes in childhood vaccination during the coronavirus disease 2019 pandemic in Japan

BackgroundThe coronavirus disease 2019 (COVID-19) pandemic has greatly affected daily life. COVID-19 often causes asymptomatic or mild disease in children; however, delayed routine childhood immunization is a concern, as it could increase the risk of vaccine-preventable disease. No study has evaluated the status of childhood vaccinations in Japan during the COVID-19 pandemic.MethodsThis retrospective observational study evaluated the number of vaccine doses administered to children in 4 Japanese cities (2 cities in the Tokyo metropolitan area and 2 cities far from Tokyo) during the period from 2016 to 2020. Vaccine doses administered between January and September 2020 during the COVID-19 pandemic were compared, by month, with those given during 2016–2019. Age-stratified demographic data were collected to determine whether factors other than change in the child population over time affected vaccination trends.ResultsIn all cities the decrease in vaccine doses administered was most apparent in March and April 2020, i.e., just before or coincident with the declaration of a nationwide COVID-19 emergency on April 7, 2020. The decrease started as early as February in the Tokyo metropolitan area. As child age increased, the decrease became more apparent. Before the lift of national emergency on May 25, catch-up of the vaccination was observed in all age groups in all cities. Vaccine doses persistently increased in older age groups but not in infants. The overall vaccination trends did not differ significantly among the 4 cities.ConclusionsThe COVID-19 pandemic significantly affected routine childhood immunization in Japan. Thus, a nationwide electronic surveillance system and announcements for guardians to encourage timely routine immunization are warranted.     

Factors associated with COVID-19 vaccination during June–October 2021: A multi-site prospective study

IntroductionVaccine hesitancy presents a challenge to COVID-19 control efforts. To identify beliefs associated with delayed vaccine uptake, we developed and implemented a vaccine hesitancy survey for the COVID-19 Community Research Partnership.MethodsIn June 2021, we assessed attitudes and beliefs associated with COVID-19 vaccination using an online survey. Self-reported vaccination data were requested daily through October 2021. We compared responses between vaccinated and unvaccinated respondents using absolute standardized mean differences (ASMD). We assessed validity and reliability using exploratory factor analysis and identified latent factors associated with a subset of survey items. Cox proportional hazards models and mediation analyses assessed predictors of subsequent vaccination among those initially unvaccinated.ResultsIn June 2021, 29,522 vaccinated and 1,272 unvaccinated participants completed surveys. Among those unvaccinated in June 2021, 559 (43.9 %) became vaccinated by October 31, 2021. In June, unvaccinated participants were less likely to feel “very concerned” about getting COVID-19 than vaccinated participants (10.6 % vs. 43.3 %, ASMD 0.792). Among those initially unvaccinated, greater intent to become vaccinated was associated with getting vaccinated and shorter time to vaccination. However, even among participants who reported no intention to become vaccinated, 28.5 % reported vaccination before study end. Two latent factors predicted subsequent vaccination—being ‘more receptive’ was derived from motivation to protect one’s own or others’ health and resume usual activities; being ‘less receptive’ was derived from concerns about COVID-19 vaccines. In a Cox model, both factors were partially mediated by vaccination intention.ConclusionThis study characterizes vaccine hesitant individuals and identifies predictors of eventual COVID-19 vaccination through October 31, 2021. Even individuals with no intention to be vaccinated can shift to vaccine uptake. Our data suggest factors of perceived severity of COVID-19 disease, vaccine safety, and trust in the vaccine development process are predictive of vaccination and may be important opportunities for ongoing interventions.     

Evaluation of mortality risk after COVID-19 vaccination,Utah 2021

IntroductionIn order to evaluate trends in death after COVID-19 vaccination we analyzed the timing of death relative to vaccination date and the causes of death in vaccinated Utahns in 2021.MethodsWe matched people in the Utah immunization registry with documented COVID-19 vaccinations between December 18, 2020 and December 31, 2021 to Utah’s 2021 vital statistics death records. Vaccinated people were categorized as having one, two, or ≥ three COVID-19 vaccine doses in a time-updated metric. We examined crude mortality rates by dosing groups in two-week intervals for all deaths, and by COVID-19 versus non-COVID-19 causes, within the 44 weeks following receipt of the most recent vaccine.ResultsWe identified 2,072,908 individuals who received at least one dose of COVID-19 vaccine of whom 10,997 died in 2021. Only 17.5 % of the total vaccinated population was age 65+, while 80.9 % of those who died were over 65. In the four weeks following the first or second vaccination, all-cause mortality was low and then stabilized for the remainder of the evaluation period at a bi-weekly average of 33.0 and 39.0 deaths/100,000 people for one and two doses, respectively. Typical seasonal variation in death was observed among those with two doses. Small sample size precluded analysis of those with ≥ three doses, but trends were similar.ConclusionsMortality rates in the 44 weeks following the COVID-19 vaccination did not show trends suggesting an increase in mortality related to COVID-19 vaccination, reinforcing the safety of COVID-19 vaccines. This represents an accessible approach for local evaluation.     

Post-COVID conditions and healthcare utilization among adults with and without disabilities—2021 Porter Novelli FallStyles survey

BackgroundAdults with disabilities are at increased risk for SARS-CoV-2 infection and severe disease; whether adults with disabilities are at an increased risk for ongoing symptoms after acute SARS-CoV-2 infection is unknown.ObjectivesTo estimate the frequency and duration of long-term symptoms (>4 weeks) and health care utilization among adults with and without disabilities who self-report positive or negative SARS-CoV-2 test results.MethodsData from a nationwide survey of 4510 U.S. adults administered from September 24, 2021–October 7, 2021, were analyzed for 3251 (79%) participants who self-reported disability status, symptom(s), and SARS-CoV-2 test results (a positive test or only negative tests). Multivariable models were used to estimate the odds of having ≥1 COVID-19–like symptom(s) lasting >4 weeks by test result and disability status, weighted and adjusted for socio-demographics.ResultsRespondents who tested positive for SARS-CoV-2 had higher odds of reporting ≥1 long-term symptom (with disability: aOR = 4.50 [95% CI: 2.37, 8.54] and without disability: aOR = 9.88 [95% CI: 7.13, 13.71]) compared to respondents testing negative. Among respondents who tested positive, those with disabilities were not significantly more likely to experience long-term symptoms compared to respondents without disabilities (aOR = 1.65 [95% CI: 0.78, 3.50]). Health care utilization for reported symptoms was higher among respondents with disabilities who tested positive (40%) than among respondents without disabilities who tested positive (18%).ConclusionsOngoing symptoms among adults with and without disabilities who also test positive for SARS-CoV-2 are common; however, the frequency of health care utilization for ongoing symptoms is two-fold among adults with disabilities.     

COVID-19 vaccine hesitancy among people living with HIV in a low-resource setting: A multi-center study of prevalence,correlates and reasons

BackgroundHesitancy to COVID-19 vaccine may worsen the burden of COVID-19 among people living with HIV (PLHIV), who are at a higher risk of COVID-19-related hospitalization and death, compared to HIV non-infected individuals. Therefore, we evaluate the predictors and reasons for COVID-19 vaccine hesitancy among unvaccinated PLHIV in six antiretroviral therapy (ART) clinics across northern Nigeria.MethodologyIn this cross-sectional study, conducted between October 2021 and February 2022 in six hospitals across two geopolitical regions of Nigeria, we utilized interviewer-administered questionnaires to assess COVID-19 vaccine hesitancy among a convenience sample of 790 eligible adult PLHIV. Hesitancy was defined as answering ‘no' or ‘maybe’ to a question asking participants their willingness to accept the COVID-19 vaccine. A multivariate logistic regression model was used to estimate the adjusted odds ratio (aOR) and 95% confidence interval (CI) of the factors associated with COVID-19 vaccine hesitancy among PLHIV.ResultsOf the total 660 unvaccinated participants included in the analysis (61.82% female, mean age [SD] of 39.76 [10.75]), 381 (57.72%) were hesitant to COVID-19 vaccine. Being 50 years and older (aOR: 0.43; 95% CI: 0.21–0.89), being unemployed (aOR: 0.57; 95% CI: 0.34–0.95), experiencing the adverse effects of ART (aOR: 0.36; 95% CI: 0.15–0.86), and perception of being at high risk of contracting COVID-19 (aOR: 0.22; 95% CI: 0.13–0.37) were associated with significantly lower odds of hesitancy. Conversely, being female (aOR: 1.64; 95% CI: 1.02–2.61) and attending ART clinics at state administrative capital cities (IIDH Kano [aOR: 2.40; 95% CI: 1.10–5.25], MMSH Kano [aOR: 5.59; 95% CI: 1.97–10.66], YSSH Damaturu [aOR: 9.88; 95% CI: 4.02–24.29] vs. GH Gashua) were associated with significantly higher odds of hesitancy. The most common reasons for hesitancy include fear of potential adverse effects, skepticism about vaccine efficacy, the rapid development of the COVID-19 vaccine, and the perceived lack of effort to develop a cure or vaccine for HIV/AIDS.ConclusionInterventions aimed at combating misperceptions and misinformation regarding the COVID-19 vaccination program may reduce the prevalence of COVID-19 vaccine hesitancy among unvaccinated PLHIV.     

School immunization coverage in adolescents during the COVID-19 pandemic: A retrospective cohort study

IntroductionFew studies have assessed the impact of the coronavirus disease 2019 (COVID-19) pandemic on immunization coverage for adolescents, and little is known about how coverage has changed throughout the pandemic. We aimed to: (1) assess the change in coverage for school-based vaccines in Alberta, Canada resulting from the pandemic; (2) determine whether coverage differed by geographic health zone and school type; and (3) ascertain whether coverage has returned to pre-pandemic levels.MethodsUsing a retrospective cohort design, we used administrative health data to compare coverage for human papillomavirus (HPV) and meningococcal conjugate A, C, Y, W-135 (MenC-ACYW) vaccines between pre-pandemic (2017–2018 school year) and pandemic (2019–2020 and 2020–2021 school years) cohorts (N = 289,420). Coverage was also compared by health zone and authority type. The 2019–2020 cohort was followed over one year to assess catch-up.ResultsCompared to 2017–2018, immunization coverage for HPV was significantly lower in the 2019–2020 (absolute difference: 60.8%; 95% CI: 60.4–61.3%) and 2020–2021 cohorts (absolute difference: 59.9%; 95% CI: 59.4–60.3%). There was a smaller, significant decline in MenC-ACYW coverage comparing 2017–2018 to 2019–2020 (absolute difference: 6.1%; 95% CI: 5.6–6.5%) and 2020–2021 (absolute difference: 32.2%; 95% CI: 31.6–32.7%). Private schools had low coverage overall, while coverage fluctuated by zone. During follow-up of the 2019–2020 cohort, coverage for HPV and MenC-ACYW increased from 5.6% to 50.2%, and 80.7% to 83.0%, respectively.ConclusionThere was a substantial decrease in school-based immunization coverage during the COVID-19 pandemic, and coverage has not returned to pre-pandemic levels, suggesting further catch-up is needed.     

Individual factors influencing COVID-19 vaccine acceptance in between and during pandemic waves (July–December 2020)

BackgroundA year after the start of the COVID-19 outbreak, the global rollout of vaccines gives us hope of ending the pandemic. Lack of vaccine confidence, however, poses a threat to vaccination campaigns. This study aims at identifying individuals’ characteristics that explain vaccine willingness in Flanders (Belgium), while also describing trends over time (July–December 2020).MethodsThe analysis included data of 10 survey waves of the Great Corona Survey, a large-scale online survey that was open to the general public and had 17,722–32,219 respondents per wave. Uni- and multivariable general additive models were fitted to associate vaccine willingness with socio-demographic and behavioral variables, while correcting for temporal and geographical variability.ResultsWe found 84.2% of the respondents willing to be vaccinated, i.e., respondents answering that they were definitely (61.2%) or probably (23.0%) willing to get a COVID-19 vaccine, while 9.8% indicated maybe, 3.9% probably not and 2.2% definitely not. In Flanders, vaccine willingness was highest in July 2020 (90.0%), decreased over the summer period to 80.2% and started to increase again from late September, reaching 85.9% at the end of December 2020. Vaccine willingness was significantly associated with respondents’ characteristics: previous survey participation, age, gender, province, educational attainment, household size, financial situation, employment sector, underlying medical conditions, mental well-being, government trust, knowing someone with severe COVID-19 symptoms and compliance with restrictive measures. These variables could explain much, but not all, variation in vaccine willingness.ConclusionsBoth the timing and location of data collection influence vaccine willingness results, emphasizing that comparing data from different regions, countries and/or timepoints should be done with caution. To maximize COVID-19 vaccination coverage, vaccination campaigns should focus on (a combination of) subpopulations: aged 31–50, females, low educational attainment, large households, difficult financial situation, low mental well-being and labourers, unemployed and self-employed citizens.     

Willingness to vaccinate children against COVID-19 declined during the pandemic

ObjectivesTo document the level of vaccine hesitancy in caregivers’ of children younger than 12 years of age over the course of the pandemic in Pediatric Emergency Departments (ED).Study designOngoing multicenter, cross-sectional survey of caregivers presenting to 19 pediatric EDs in the USA, Canada, Israel, and Switzerland during first months of the pandemic (phase1), when vaccines were approved for adults (phase2) and most recently when vaccines were approved for children (phase3).ResultsWillingness to vaccinate rate declined over the study period (59.7%, 56.1% and 52.1% in the three phases). Caregivers who are fully vaccinated, who have higher education, and those worried their child had COVID-19 upon arrival to the ED, were more likely to plan to vaccinate in all three phases. Mothers were less likely to vaccinate early in the pandemic, but this hesitancy attenuated in later phases. Older caregivers were more willing to vaccinate, and caregivers of older children were less likely to vaccinate their children in phase 3. During the last phase, willingness to vaccinate was lowest in those who had a primary care provider but did not rely on their advice for medical decisions (34%). Those with no primary care provider and those who do and rely on their medical advice, had similar rates of willingness to vaccinate (55.1% and 52.1%, respectively).ConclusionsCOVID-19 vaccine hesitancy is widespread and growing over time, and public health measures should further try to leverage identified factors associated with hesitancy in order to enhance vaccination rates among children.     

Efficacy and safety of the BNT162b2 mRNA COVID-19 vaccine in participants with a history of cancer: subgroup analysis of a global phase 3 randomized clinical trial

IntroductionIndividuals with an underlying malignancy have high risk of poor COVID-19 outcomes. In clinical trials, COVID-19 vaccines were safe and efficacious against infection, hospitalization, and death, but most trials excluded participants with cancer. We report results from participants with a history of past or active neoplasm (malignant or benign/unknown) and up to 6 months’ follow-up post-dose 2 from the placebo-controlled, observer-blinded trial of the 2-dose BNT162b2 mRNA COVID-19 vaccine.Patients and methodsBetween July 2020–January 2021, 46,429 participants aged ≥ 12 years were randomized at 152 sites in 6 countries. Healthy participants with pre-existing stable neoplasm could participate; those receiving immunosuppressive therapy were excluded. Data are reported for participants, aged ≥ 16 years for safety and ≥ 12 years for efficacy, who had any history of neoplasm at baseline (data cut-off: March 13, 2021). Adverse-event (AE) data are controlled for follow-up time before unblinding and reported as incidence rates (IRs) per 100 person-years follow-up.ResultsAt baseline, 3813 participants had a history of neoplasm; most common malignancies were breast (n = 460), prostate (n = 362), and melanoma (n = 223). Four BNT162b2 and 71 placebo recipients developed COVID-19 from 7 days post-dose 2; vaccine efficacy was 94.4% (95% CI: 85.2, 98.5) after up to 6 months’ follow-up post-dose 2. This compares favorably with vaccine efficacy of 91.1% in the overall trial population after the same follow-up. AEs were reported at IRs of 95.4 (BNT162b2) and 48.3 (placebo) per 100 person-years. Most common AEs were reactogenicity events (injection-site pain, fatigue, pyrexia). Three BNT162b2 and 1 placebo recipients withdrew because of vaccine-related AEs. No vaccine-related deaths were reported.ConclusionIn participants with past or active neoplasms, BNT162b2 vaccine has a similar efficacy and safety profile as in the overall trial population. These results can inform BNT162b2 use during the COVID-19 pandemic and future trials in participants with cancer.Clinical trial number: NCT04368728.     

Methodological changes implemented over time to support accurate and timely COVID-19 vaccine coverage estimates: Ontario,Canada

AbstractThe COVID-19 vaccination program implementation in Ontario, Canada has spanned multiple years and is ongoing. To meet the challenges of the program, Ontario developed and implemented a new electronic COVID-19 immunization registry, COVaxON, which captures individual-level data on all doses administered in the province enabling comprehensive coverage assessment. However, the need for ongoing COVID-19 vaccine coverage assessments over a multi-year vaccination program posed challenges necessitating methodological changes. This paper describes Ontario’s COVID-19 immunization registry, the methods implemented over time to allow for the ongoing assessment of vaccine coverage by age, and the impact of those methodological changes.Throughout the course of the vaccination program, four different methodological approaches were used to calculate age-specific coverage estimates using vaccination data (numerator) obtained from COVaxON. Age-specific numerators were initially calculated using age at time of first dose (method A), but were updated to the age at coverage assessment (method B). Database enhancements allowed for the exclusion of deceased individuals from the numerator (method C). Population data (denominator) was updated to 2022 projections from the 2021 national census following their availability (method D). The impact was most evident in older age groups where vaccine uptake was high. For example, coverage estimates for individuals aged 70–79 years of age for at least one dose decreased from 104.9 % (method B) to 95.0 % (method D). Thus, methodological changes improved estimates such that none exceeded 100 %.Ontario’s COVID-19 immunization registry has been transformational for vaccine program surveillance. The implementation of a single registry for COVID-19 vaccines was essential for comprehensive near real-time coverage assessment, and enabled new uses of the data to support additional components of vaccine program surveillance. The province is well positioned to build on what has been achieved as a result of the COVID-19 pandemic and expand the registry to other routine vaccination programs.